Manager, Clinical Data and Reporting Standards - SDTM Programming (Hybrid)

About the role

The Manager, Clinical Data and Reporting Standards (CDARS) plays a crucial role in developing and implementing data and reporting standards for AbbVie's clinical trials. This individual is responsible for ensuring compliance with CDISC standards and industry best practices, as well as contributing to the development of pipeline-based SDTM.

Responsibilities

• Actively participates in defining standards within assigned therapeutic areas, including Data Collection, Data Review Rules, SDTM mapping, ADaM mapping, and study-level tables, listings, or figures.
• Ensures consistency across standard types and develops training materials for proper use of standards in pipeline activities.
• Provides feedback on CRF design and SDTM datasets to ensure compliance with CDISC standards and AbbVie's extensions.
• Reviews and provides feedback on SDTM Trial Design Domains and SDTM Programming based on specifications.
• Oversees the creation of SDTM datasets, defines.xml, annotated CRFs, and Clinical Study Data Reviewer’s Guides for both FDA and PMDA submissions.
• Consults on conformance issues for SDTM and/or ADaM and works with the study team to resolve problems.
• Represents AbbVie's interests in industry standards development projects and stays current with regulatory requirements.
• Identifies and drives improvements to processes and content of standards.

Qualifications

• MS with 8 years of relevant clinical research experience, or BS with 10 years of relevant clinical research experience.
• Experience with SDTM is required.
• Experience leading development of standards for data collection, tabulation, analysis, and/or reporting.
• Experience with preparing SDTM and/or ADaM datasets and documentation for regulatory submissions.
• Experience with CDASH is highly recommended.
• Experience with ADaM, Analysis Results Metadata, or TLF standards is helpful.
• Active participation in CDISC teams is preferred.

Additional Information

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.